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A Study of CC-99677 in Participants With Active Ankylosing Spondylitis (AS SpA axSpA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04947579
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:
This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Drug: CC-99677 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis
Actual Study Start Date : August 25, 2021
Estimated Primary Completion Date : November 22, 2023
Estimated Study Completion Date : February 14, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Administration of CC-99677 150 mg QD PO
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
Drug: CC-99677
Oral

Experimental: Administration of CC-99677 60mg QD PO
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
Drug: CC-99677
Oral

Placebo Comparator: Administration of Placebo QD PO
49 participants will be randomized to placebo in biologic naive main study
Other: Placebo
Oral

Experimental: Administration of CC-99677 150 mg QD PO.
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
Drug: CC-99677
Oral

Experimental: Administration of CC-99677 60mg QD PO.
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
Drug: CC-99677
Oral

Placebo Comparator: Placebo additional dose cohort
10 participants will be randomized to placebo in biologic-failure substudy
Other: Placebo
Oral




Primary Outcome Measures :
  1. Assessment of ASAS 20 [ Time Frame: Up to week 12 ]
    The Assessment In Spondyloarthritis International Society (ASAS) 20 is defined as improvement ≥ 20% and ≥ 1 unit on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.


Secondary Outcome Measures :
  1. Assessment of ASAS 40 [ Time Frame: Up to week 12 ]
    The Assessment In Spondyloarthritis International Society (ASAS) 40 is defined as improvement ≥ 40% and ≥ 2 units on a scale of 0 to 10 in each of the 3 domains, with no worsening in the fourth, where the domains are physical function, total back pain, patient global assessment of disease, and inflammation.

  2. Assessment of ASDAS-CRP [ Time Frame: Up to week 12 ]
    The Ankylosing Spondylitis Disease Activity with C-reactive protein as the acute-phase reactant (ASDAS-CRP)is a validated disease activity index in AS that combines participant reported assessments of back pain, morning stiffness, joint pain and/or swelling and general wellbeing.

  3. Assessment of BASDAI [ Time Frame: Up to week 12 ]
    The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a composite score based on a participant self-administered survey of six questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the participant major symptoms of AS.

  4. Assessment of BASFI [ Time Frame: Up to week 12 ]
    The Bath Ankylosing Spondylitis Functional Index (BASFI) is a composite score based on a participant self-administered survey of ten questions using a 0 to 10 unit numerical rating scale (NRS) that assesses a participant's degree of mobility and functional ability.

  5. SPARCC score for the total spine and sacroiliac joints [ Time Frame: Up to week 12 ]
    Spinal and sacroiliac joint inflammation as measured by Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) score of sacroiliac joints and spine.

  6. High-sensitivity C-reactive protein (hsCRP) [ Time Frame: Up to week 12 ]
    High-sensitivity C-reactive protein (hsCRP) provides an objective measure of disease activity in participants.

  7. Incidence of Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.



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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria
  • Active axial disease at Screening and Baseline defined by a Bath Ankylosing
  • Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4
  • Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each
  • Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody [mAb] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS

Exclusion Criteria:

  • Radiographic evidence of total ankylosis of the spine
  • Clinically significant back pain caused by diseases other than AS
  • Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents
  • Participation in any study of an investigational drug, including those for COVID-19
  • History of malignancy
  • Oral corticosteroids (prednisone or equivalent) > 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947579


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb, MD Bristol-Myers Squibb
Additional Information:
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04947579    
Other Study ID Numbers: CC-99677-AS-001
U1111-1265-3951 ( Registry Identifier: UTN Number )
2019-004108-37 ( EudraCT Number )
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Ankylosing Spondylitis
CC-99677
MK2inhibitor
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis